APO PIROXICAM CAP 20MG CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PIROXICAM

Tersedia dari:

APOTEX INC

Kode ATC:

M01AC01

INN (Nama Internasional):

PIROXICAM

Dosis:

20MG

Bentuk farmasi:

CAPSULE

Komposisi:

PIROXICAM 20MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0114612001; AHFS:

Status otorisasi:

MARKETED

Tanggal Otorisasi:

1986-12-31

Karakteristik produk

_APO-PIROXICAM (Piroxicam capsules) _
_ _
_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-PIROXICAM
Piroxicam Capsules
Capsules, 10 mg and 20 mg, For Oral Use
Apotex Standard
Nonsteroidal Anti-inflammatory Drug (NSAID)
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Initial Authorization:
MAR 03, 1986
Date of Revision:
MAY 16, 2023
Submission Control No: 271164
_APO-PIROXICAM (Piroxicam capsules) _
_ _
_Page 2 of 44 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNING AND PRECAUTIONS BOX
05/2023
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
05/2023
7 WARNINGS AND PRECAUTIONS, Skin
05/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations
05/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
........................................................................................
2
TABLE OF CONTENTS
..........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics (< 16 years of age):
......................................................................................
4
1.2
Geriatrics (> 65 years of age):
......................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
......................................................................
5
4
DOSAGE AND ADMINISTRATION
...................................................................................
6
4.1
Dosing Considerations
.................................................................................................
6
4.2
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